Kornimate/medical-research-clean huggingface dataset:
mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical mesothelial hyperplasia

Conditions: Malignant Mesothelioma; Metastatic Cancer

Summary: rationale: studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer. purpose: this research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

objectives: primary * determine if mesothelin and osteopontin in serum can serve as early markers of malignant transformation into mesothelioma. secondary * determine if there are cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples. * determine if sv40 has a carcinogenic role. * determine the relationship between the serum concentration of mesothelin and/or osteopontin and the expression of other markers and with clinical progression. outline: this is a multicenter study. levels of mesothelin and osteopontin in serum (and pleural fluid, if effusion is present) are measured at baseline and 3, 6, 12, and 24 months. patients with mesothelioma, reactional lesions, or adenocarcinoma undergo tomodensitometry (tdm) at baseline, 3, 6, and 12 months. patients with pleural plaques only undergo tdm at 12 months. patients are followed for 5 years.

Eligibility criteria:
disease characteristics: inclusion criteria: * diagnosis of mesothelial hyperplasia and meeting 1 of the following criteria: * confirmed prior exposure to asbestos and presence of pleural effusion and meets 1 of the following diagnostic criteria: * mesothelioma * mesothelial hyperplasia of unspecified malignancy * reactional inflammatory hyperplasia * no asbestos exposure but pleural effusion with pleural malignant mesothelioma or pulmonary metastasis * prior exposure to asbestos, no pleural effusion, and asymptomatic (pleural plaques present) * no prior exposure to asbestos but with benign pleural effusion * tissue obtained by pleuroscopy, surgical biopsy, or video-thoracoscopy available * paraffin-embedded and frozen tissue available exclusion criteria: * solitary fibrous tumor * diffuse pleural fibrosis * purulent pleurisy patient characteristics: * not specified prior concurrent therapy: * no prior chemotherapy or radiotherapy

Keywords: localized malignant mesothelioma lung metastases malignant pleural effusion
standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-iiia breast cancer receiving radiation therapy, cope study

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Breast Carcinoma

Summary: this clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-iiia breast cancer receiving radiation therapy. beginning radiation therapy for breast cancer can be stressful. education about what to expect often reduces the stress, anxiety, and depression experienced by these patients. this study is being done to see how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy for patients with breast cancer.

primary objective: i. assessment of patient reported anxiety and depression, confidence with information, and side effect expectations of radiation therapy following counseling with or without photo guide at pre-treatment, 2 weeks, 6 months, and 12 months. secondary objective: i. efficacy of intervention to impart reasonable expectations of the side effect burden of radiation therapy (rt). exploratory objective: i. picture guide book. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo verbal counseling and view a photo guide. patients also complete questionnaires at 2 weeks, 6 and 12 months. arm ii: patients undergo verbal counseling. patients also complete questionnaires at 2 weeks, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * breast cancer patients diagnosed with stage 0-iiia disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment * patients must have the ability to read and understand english exclusion criteria: * patients who are planned for ultra-hypofractionated radiation treatment * patients who are planned for partial breast radiation treatment * patients who are planned to receive concurrent radiosensitizing chemotherapy
evaluation of the relationship between muscle architecture and muscle strength in female gonarthrosis patients

Conditions: Osteo Arthritis Knee; Gonarthrosis; Osteoarthritis

Summary: the goal of this cross-sectional study is to evaluate muscle architecture changes and it's effect on muscle strength in female patients with gonarthrosis.main questions are: * is there any correlation between muscle strength and muscle thickness, pennation angle fiber length? * is there any muscle architecture difference in gonarthrosis and is it effecting the muscle strength? the investigators will enroll patients with unilateral gonarthrosis so that investigators can compare the changes within osteoarthritic and healthy knee with the same physical activity levels.

knee osteoarthritis (oa) is a chronic disease characterized by morning stiffness, reduced joint range of motion, chronic pain, and decreased muscle strength, leading to functional limitations as the disease progresses . in patients with knee osteoarthritis, all muscles of the hip, knee, and ankle are affected in some way . evidence suggests that impairments in muscle strength in the lower extremities contribute to increased pain and joint space narrowing. voluntary muscle contractions lead to various changes in muscle architecture, including changes in fascicle angle and pennation angle as well as muscle thickness. while muscle cross-sectional area and thickness are primarily associated with the magnitude of generated force, parameters such as pennation angle have been found to be more related to explosive force. ultrasonography (us) is a non-invasive imaging method that can visualize these changes. muscle architecture parameters obtained from us can provide reliable data related to muscle contractility independently of surrounding muscles. furthermore, us is considered to have similar validity to mri imaging, which is the gold standard for displaying muscle architecture. additionally, isometric muscle strength can be reliably measured using handheld dynamometers. although studies have investigated the relationship between muscle strength and muscle architecture determined by us in patients with knee oa, these studies have predominantly examined the relationship in the quadriceps muscle, and muscles associated with the ankle have not been studied extensively.

Eligibility criteria:
inclusion criteria: * to be ≥18 years of age, * presence of unilateral knee oa (according to american college of rheumatology criteria), * presence of knee oa with kellgren/lawrence (k/l) stage ≥2, * ability to live independently, * ability to walk without assistive devices. exclusion criteria: * history of surgery on the spine or lower extremities, * history of inflammatory rheumatic disease, * severe cardiovascular disease, * neuromuscular disease affecting muscle strength, * individuals following a regular exercise program, * secondary osteoarthritis.
epidemiology and pathogenesis of hiv-associated pulmonary hypertension

Conditions: HIV Infection; Pulmonary Hypertension; Endothelial Function; HIV Infections

Summary: the purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with hiv infection and to investigate its pathogenesis. we propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (haart) and viral suppression in hiv-infected patients who have been identified to have pre-clinical pulmonary hypertension (aim 1). in addition, we will investigate the mechanistic role of the hiv-1 nef protein and hhv-8 infection in the development and progression of pulmonary hypertension in individuals with hiv (aim 2). we will also investigate endothelial function in hiv-infected patients with pulmonary hypertension (aim 3).


Eligibility criteria:
inclusion criteria: 1. infection with hiv greater than 6 months in duration 2. right heart catheterization showing pasp \> 30mm hg 3. ability to provide reliable history of hiv medications or has received the majority of medical care from san francisco general hospital with available records of medical treatment. 4. ability to participate in follow-up for the duration of the study. exclusion criteria: 1. known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy. 2. any known pulmonary disease that could potentially cause pulmonary hypertension. 3. a po2 by pulse oximetry below 90% on room air. 4. obstructive sleep apnea. 5. known collagen vascular disease. 6. history of anorexigen use * 7. age less than 18 years old. * 8. other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.

Keywords: hiv infection pulmonary hypertension endothelial function antiretroviral medication treatment experienced
rapid acute coronary syndrome exclusion using high-sensitivity i troponin

Conditions: Chest Pain; Myocardial Ischemia

Summary: as part of the planned implementation of a new clinical pathway using hs-ctni, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ed).

this is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected acs using the beckman hs-ctni assay. as the new protocol is executed across 9 eds within an integrated health system, the investigators will study its effects on patient and system-level metrics. a modified stepped wedge design will be utilized that allows comparison of the race-it pathway with standard of care management

Eligibility criteria:
inclusion criteria: * patients ≥18 years old presenting to the ed for whom a treating clinician suspects acs and orders a baseline ecg and cardiac troponin. exclusion criteria: 1. st-segment myocardial infarction (stemi) leading to immediate reperfusion therapy 2. any ed-drawn hs-ctni value \> 99th percentile (18 ng/l) 3. clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident) 4. a transfer from another facility 5. primary residence outside the state of michigan 6. previous inclusion in the study 7. enrolled in hospice

Keywords: high-sensitivity troponin chest pain
effectiveness of self-care rests on knowledge, self-care and cardiometabolic control of adult men with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: this research project has the main objective to analyze the benefits of self-care supported for adult men with diabetes mellitus. treat yourself will randomized-controlled clinical study, randomized cluster to be developed with men aged between 40 and 70 years who have type 2 diabetes and are registered with the health strategy teams of the municipality of family maringa. the recruited subjects will be randomly allocated into two groups: intervention group and control group. in the first, individuals will participate in a self-care intervention supported by a nurse, based on supported self-care and behavior change protocol; and second, individuals participate in conversation circles and will have the assistance normally provided by health services. the follow-up will take place for six months and will be collected information: socioeconomic, demographic, behavioral health, complications, laboratory and anthropometric. it is intended, through this study, demonstrate the effectiveness of this type of intervention, user-centric, on the health of men with dm, reinforcing this option of choice for professionals and users within the primary health care (phc).


Eligibility criteria:
inclusion criteria: * having medical diagnosis of dm2; * being male; * age between 20 and 59 years; * is domiciled in the city of maringa in the fhs coverage area; being part of the esf families register. * being able to answer the questions of data collection instruments; * relate visual ability , hearing and locomotor to perform self-care; * have telephone contact (mobile or fixed) for monitoring the program. exclusion criteria: * present lesions in target organs (brain, heart, kidneys, eyes) or comorbidities/complications resulting from diabetes, recorded in medical records, such as chronic renal failure; * have psychological or other disorders , registered in the medical records, and that compromise the understanding of the study, who do not agree or do not have availability to participate in the intervention; * moving to another location that does not have coverage of the esf, or even to another city.
neural mechanisms of motor and cognitive networks

Conditions: Normal Volunteers; Cognition Disorders; Motor Disorders

Summary: this study investigates the neural mechanisms of motor and cognitive networks using cognitive assessment, reaction time measurement, high-density eeg and fmri.


Eligibility criteria:
inclusion criteria (for healthy people): * right handed, * no history of psychological/psychotic problems, * no history of important diseases. exclusion criteria (for healthy people): * being pregnant or breast feeding * having any non-mri compatible conditions inclusion criteria (for patients): * right handed * in a stable condition * ability to follow complex commands exclusion criteria (for patients): * having any non-mri compatible conditions * inability to perform required tasks
acute effects of deep-slow breathing exercise and cranial-visceral manual therapy on ans parameters in healthy adults

Conditions: Autonomic Nervous System

Summary: the purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. the measurements will take place right before and after the intervention to evaluate the effects of one single intervention.

all the patients will be clearly informed and will be included in the present study after their informed consent. the autonomic nervous system (ans) will be evaluated using bio-sensors such as photoplethysmography (ppg) and galvanic skin response (gsr). the measurements will take place once for an individual. there will be three groups consisted of manual therapy, deep-slow breathing, and control groups. non-invasive cranial and visceral techniques will be applied on the manual therapy group. the deep-slow breathing group will get an intervention consisting of deep-paced breathing to increase cardiac harmony. the control group will rest for the same amount of time as other interventions to distinguish whether the changes are related to intervention. after given consent, the participant will be assigned randomly to one of three groups. all the participants will be subjected to baseline measurement of the abovementioned metrics prior to intervention. all the interventions will take place in a controlled setting. after baseline measurement, the participant will take one of the three interventions which will take 30 minutes. after the data for each person is captured via sensors, it will be stored on a personal computer for further analysis and interpretation. according to investigator's hypothesis, deep-slow breathing group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.

Eligibility criteria:
inclusion criteria: * to be between 18- 30 years old. * to volunteer to participate in the study * not engaging in regular exercise. * not to have a chronical disease or history of chronical disease. * not to take any medication that affects heart rate variability. exclusion criteria: * being outside of the range of 18- 30 years old. * to have any kind of medical condition that disturbs the autonomic nervous system * to have a chronical disease * to have a regular medication * to have/had head injury, intracranial bleeding or increased intracranial pressure.

Keywords: deep-slow breathing, manual therapy
safety and tolerability study of lu af11167 after repeated dosing in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the safety and tolerability of lu af11167 in patients with schizophrenia following various repeated dosing regimens of lu af11167 (alone or as added treatment to risperidone).


Eligibility criteria:
inclusion criteria: * man or woman aged ≥18 years and ≤60 years with a body mass index (bmi) of ≥18.5 and ≤38 m2 * primary diagnosis of schizophrenia according to dsm-iv-tr™ (codes 295.10, 295.20, 295.30, 295.90) * clinical global impression - severity of illness (cgi-s) score ≤4 (moderately ill) at the screening visit and baseline visit (day -1) * panss total score ≤80 at the screening visit and the baseline visit (day -1) * score of 4 (moderate) of the following panss items at the screening visit and the baseline visit (day -1): p7 (hostility), g8 (uncooperativeness) * minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four clinical global impression of severity (cgi-s) items of the esrs-a; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the screening visit and the baseline visit * willingness to be hospitalised for approximately 3 weeks after the baseline visit (day -1) exclusion criteria: * the patient experienced an acute exacerbation requiring hospitalization within the last 6 months * the patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks other pre-defined inclusion and exclusion criteria may apply
protocol no. 2016 - calculosis- endourology;

Conditions: Calculosis

Summary: retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.

clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications. these data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory. furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae. all this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.

Eligibility criteria:
inclusion criteria: * subjects suffering from kidney stones or tumors of the upper excretory tract \>= 18 years * signature of informed consent exclusion criteria: * subjects \< 18 years * presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Keywords: calculosis calculi endourologia
evaluation of quality indicators on analgesia, sedation and delirium in intensive care patients and their impact on outcome indicators and economic indicators

Conditions: Delirium; Pain

Summary: retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.

the evaluation of quality-related process indicators (in this case, quality indicator ii of the intensive care quality indicators of the divi\*: management of analgesia, sedation and delirium) will be correlated with economic parameters of the treatment from economic data (drg revenue, case costs). data from clinical routine care from the charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). the aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. in addition, further routine data, which may represent influencing factors like comorbidities (charlson comorbitity index) are calculated using the icd-10 coding. also procedures using the ops system are evaluated. in this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. the analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers. (\* divi: deutsche interdisziplinäre vereinigung für intensiv- und notfallmedizin = german interdisciplinary association for intensive care and emergency medicine)

Eligibility criteria:
inclusion criteria: * age ≥ 18 years exclusion criteria: * incomplete electronic records

Keywords: sedation